NEUROFAX JE-120A-22

GUDID 00841983103810

128 CHANNEL AMPLIFIER for JE-120A

NIHON KOHDEN AMERICA, INC.

Neurophysiologic monitoring system
Primary Device ID00841983103810
NIH Device Record Keyb2478b36-c30e-40cf-ae65-f355b67d4d5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEUROFAX
Version Model NumberJE-120A-22
Catalog NumberJE-120A-22
Company DUNS021063219
Company NameNIHON KOHDEN AMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841983103810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLTNon-normalizing quantitative electroencephalograph software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-01
Device Publish Date2016-09-24

On-Brand Devices [NEUROFAX]

00841983103988MEDICAL ISOLATION TRANSFORMER
00841983103971NEUROFAX ACQUISITION, Dell Precision Tower desktop
00841983103926EEG REVIEW SUITE, 5 USER LICENSE
00841983103919EEG REVIEW SUITE, 10 USER LICENSE
00841983103858LIVE VIEW PANEL SYSTEM
00841983103841EEG REVIEW SYSTEM
00841983103834256 CHANNEL AMPLIFIER for JE-120A
00841983103827192 CHANNEL AMPLIFIER for JE-120A
00841983103810128 CHANNEL AMPLIFIER for JE-120A
00841983103803NEUROFAX EEG DIGITAL, PORTABLE
00841983103797NEUROFAX ACQUISITION, PANEL PC
00841983103773NEUROFAX ACQUISITION, SML FRM
00841983103650EEG REVIEW SUITE, MULTIUSE
00841983103209NEUROFAX EEG DIGITAL, TOWER
00841983102417Neurofax Electroencephalograph
00841983104329NEUROFAX ACQUISITION, SML FRM

Trademark Results [NEUROFAX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NEUROFAX
NEUROFAX
73597401 1433703 Live/Registered
NIHON KOHDEN CORPORATION
1986-05-07

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